CrystalGenomics Designated for Priority Review of Pancreatic Cancer Treatment 'Ivaltinostat'

[Asia Economy Reporter Hyunseok Yoo] CrystalGenomics announced on the 9th that its pancreatic cancer treatment drug, Ivaltinostat, has been designated as a fast-track review drug by the Ministry of Food and Drug Safety (MFDS), marking the first time an anticancer new drug has received such designation.

Through this fast-track review designation, Ivaltinostat will be able to shorten the period until new drug approval.

Drugs designated for fast-track review complete the review process within 90 days during new drug approval. Additionally, the MFDS stipulates priority review and pre-consultation for fast-track drugs, providing the advantage of enhancing both the speed and accuracy of new drug approval.

The designation of Ivaltinostat as a fast-track review drug is significant as it is the first anticancer new drug candidate developed by an innovative pharmaceutical company to receive this designation.

Previously, the MFDS established the ‘fast-track review system,’ similar to the U.S. Food and Drug Administration (FDA)’s Fast Track, and reorganized the responsible organization to shorten the product development period of pharmaceuticals while expanding treatment opportunities for safe and novel medical products.

In particular, pancreatic cancer is a difficult-to-treat cancer type with a market value expected to reach $2.3 billion by 2026, yet currently lacks adequate treatment options.

Ivaltinostat is an epigenetic disease-targeting HDAC inhibitor that demonstrated superior safety and efficacy compared to existing standard treatments in a Phase 2 clinical trial for advanced or metastatic pancreatic cancer conducted at Yonsei University College of Medicine’s Severance Hospital in Sinchon, indicating high growth potential.

Currently, CrystalGenomics is also focusing on expanding indications of Ivaltinostat beyond pancreatic cancer to other cancers such as hepatocellular carcinoma (HCC) and myelodysplastic syndrome (MDS), as well as chronic diseases like fibrosis, based on its excellent safety profile.

As late-stage clinical trials for pancreatic cancer are approved and progress, the expansion of indications to other diseases will accelerate, further highlighting the value of Ivaltinostat’s multiple pipelines.

A CrystalGenomics representative stated, “Through the fast-track review designation, we expect that Ivaltinostat will become a new treatment option more quickly for patients with inoperable advanced or metastatic pancreatic cancer as a first-line therapy.”

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